Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Investigation of the Effects of Neuromuscular Electrical Stimulation in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612115
• Other study ID #: 2217-GOA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: September 28, 2017

Study information

• Verified date: August 2018
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the effects of neuromuscular electrical stimulation on peripheral muscles and other physical and psychosocial variables in patients with pulmonary arterial hypertension. This study was designed as an assessor-blind randomized controlled trial. Thirty-one patients with pulmonary arterial hypertension will be recruited. The participants will randomly divided two parallel groups as treatment and control. For the treatment group, neuromuscular electrical stimulation will be applied to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Control group will not be received any additional treatment, just given healthy life recommendations such as walking. The participants will be assessed before and after the treatment by a blind assessor to the group allocation. The outcome measure will be assessments of the upper and lower limb muscle strength, respiratory muscle strength, muscle cross-sectional area and thickness, pulse wave velocity, exercise capacity, walking speed, functional mobility and balance performances, balance confidence, fatigue perceptions, physical activity level, activities of daily living and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elevated pulmonary artery pressures measured by right heart catheterization

• New York Heart Association class II or III

• Stabile Pulmonary Arterial Hypertension-specific pharmaceutical therapy for 3 months

Exclusion Criteria:

• Orthopaedic problems

• Significant restrictive or obstructive pulmonary disease

• Acute cor pulmonale.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Device:
• Neuromuscular electrical stimulation
Neuromuscular electrical stimulation to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Device name: Four-channel Wireless Professional (DJO United Kingdom Ltd., Chattanooga, France)

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric muscle strength	Isometric muscle strength for knee extensors	Change from Baseline at 8 weeks
Secondary	Isometric muscle strength	Isometric muscle strength for shoulder flexors and abductors	Change from Baseline at 8 weeks
Secondary	Hand grip strength	Hand grip strength	Change from Baseline at 8 weeks
Secondary	Quadriceps femoris muscle thickness		Change from Baseline at 8 weeks
Secondary	Rectus femoris cross-sectional area		Change from Baseline at 8 weeks
Secondary	Pulse wave velocity		Change from Baseline at 8 weeks
Secondary	Six-Minute Walk Test		Change from Baseline at 8 weeks
Secondary	Six-Minute Pegboard and Ring Test		Change from Baseline at 8 weeks
Secondary	Sit-to-Stand Test		Change from Baseline at 8 weeks
Secondary	Timed-Up and Go Test		Change from Baseline at 8 weeks
Secondary	Activities-specific Balance Confidence Scale	The Activities-specific Balance Confidence Scale is a 16-item instrument designed to measure a patient's perceived level of confidence in performing common activities of daily living without losing balance and falling. The patient ranks his confidence to complete each item from 0% (no confidence) to 100% (complete confidence). Total score is calculated as sum score ranged from 0 to 100. Higher scores indicate higher balance confidence level.	Change from Baseline at 8 weeks
Secondary	4-m Gait Speed Test		Change from Baseline at 8 weeks
Secondary	Fatigue Impact Scale	The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Higher scores indicate the greater level of fatigue (total score ranged from 0 to 160).	Change from Baseline at 8 weeks
Secondary	International Physical Activity Questionnaire-Short Form	The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.	Change from Baseline at 8 weeks
Secondary	Milliken Activities of Daily Living Scale	Milliken Activities of Daily Living Scale consists of 47 items including preparing meals, and eating (8 items), self-care (9 items), dressing oneself (8 items), manual manipulation of objects (9 items), house cleaning, and washing clothes (7 items), and other activities (6 items). For scoring the level of ability to perform each item, a 5-point scale, and for the level of necessity to perform these items, a 3-point scale is used. Total score can range from 0 to 705 points. Higher scores indicate less limitation in activities of daily living.	Change from Baseline at 8 weeks
Secondary	Nottingham Health Profile	Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.	Change from Baseline at 8 weeks